AMICUS Separator System

Separator, Automated, Blood Cell, Diagnostic

Fresenius Kabi AG

The following data is part of a premarket notification filed by Fresenius Kabi Ag with the FDA for Amicus Separator System.

Pre-market Notification Details

Device IDK200530
510k NumberK200530
Device Name:AMICUS Separator System
ClassificationSeparator, Automated, Blood Cell, Diagnostic
Applicant Fresenius Kabi AG 3 Corporate Drive Lake Zurich,  IL  60047
ContactKim Forch
CorrespondentKim Forch
Fresenius Kabi AG 3 Corporate Drive Lake Zurich,  IL  60047
Product CodeGKT  
CFR Regulation Number864.9245 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-02
Decision Date2020-09-11

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